RETROSPECTIVE STUDY OF THE EFFICACY, ECONOMY AND SAFETY OF TREATMENT WITH SUBCUTANEOUS INJECTION OF BORTEZOMIB IN DE NOVO PATIENTS WITH MULTIPLE MYELOMA
(Abstract release date: 05/19/16)
EHA Library. Fu C. 06/09/16; 134902; PB2002
Prof. Dr. Chengcheng Fu
Contributions
Contributions
Abstract
Abstract: PB2002
Type: Publication Only
Background
Multiple myeloma(MM) is a clonal plasma cell malignancy. NCCN guidelines recommended bortezomib-based therapies as the first front-line treatment in patients with newly diagnosed and relapsed multiple myeloma. Oakervee H E, et al proved that PAD combination (bortezomib/doxorubicin/dexamethasone) can improve survival for previously untreated MM patients.Peripheral neuropathy(PN) is a well-known and unavoidable side effect of bortezomib, which is limited to the usage for some patients. The multi-centers clinical research suggested that subcutaneous administration of bortezomib was non-inferior to the standard intravenous route of delivery but could reduce side-effects of bortezomib, particularly in peripheral neuropathy. But China is lack of data about the usage of bortezomib.
Aims
To explore the efficacy and safety of subcutaneous injection of bortezomib in the treatment of de novo MM patients.
Methods
A total of 57 MM patients treated with bortezomib, adriamycin and dexamethasone form June 2008 to January 2015 were analyzed. Among them 28 received conventional PADiv with the intravenous bolus of bortezomib and another 29 received PADih with the subcutaneous injection of bortezomib. The efficacy and safety of two groups were evaluated.
Results
The overall response rate was 94.6% of all patients after four courses of PAD induction.67.9%, 32.1% in PADiv group and 60.7%,30.4% in PADih group achieved response>=VGPR and sCR/CR. The median follow-up of PADiv group was 40(1.5-73) months and PADih was 20(1.5-30) months. There was no difference of TTP and DFS between Two groups. But PADih group showed a more favorable OS (p=0.004)even though with a shorter period of follow-up. The statistical results showed that the most common hematologic toxicities of grade 3/4 in the PAD group were granulopenia(67.9%), leukopenia(67.9%), thrombocytopenia (67.9%) and anemia (35.7%), and non-hematologic toxicities of grade 3/4 mainly included infection (39.3%), constipation (25%), diarrhea (21.4%), peripheral neuropathy(21.4%), fever (21.4%), VZV infection (17.9%) and anorexia (17.6%). Accordingly, the hematologic toxicities of grade 3/4 in the PADih group were granulopenia(55.2%), thrombocytopenia (51.7%), leukopenia(41.4%), anemia(41.4%) and non-hematological toxicities were mainly constipation(34.5%), nausea(27.6%), anorexia(17.2%), diarrhea (17.2%) and vomiting(10.3%). A total of 27 patients(47.4%) treated with Velcade suffered from peripheral neuropathy. Incidence of PN of two groups even grade 3/4 showed no statistic difference. 39.3% PADiv patients were infected during the treatment and 3 died from severe pneumonia. The incidence of infection in PADiv and PADih group shows great difference(P=0.000). Among other grade 3/4 adverse reactions, only data of leukopenia(P=0.045) and VZV infection(P=0.023) show differences. Remarkably, six patients (21.4%) receiving PADiv due to severe PN reduced dose of Velcade or Suspended treatment. Patients treated with PADih did not appear serious infection. Average length of hospital stay per circle of PADih and PADiv group is 24, 15 days, respectively (P = 0.000). Comparison of supportive therapies including G-CSF, platelets transfusion, resuscitation, prevention of infection, nutrition and bortezomib reduction or suspension through chi-square analysis showed that proportion of platelet transfusion and prevention of infection was statistically significant (P = 0.094; P = 0.091) when alpha = 0.1. Ratio of resuscitation, anti-infection drugs, suspension or reduction of bortezomib in PADiv group is higher(P = 0.009; P = 0.002; P = 0.011).
Conclusion
The PADih regimen by changing bortezomib from intravenous bolus to subcutaneous injection significantly reduced adverse events, improved the safety of clinical application of bortezomib without affecting curative effect, and had greatly improved the overall survival due to lower incidence of infection in the PADih patients. In addition, subcutaneous bortezomib could obviously reduce the length of stay in hospital per circle and incidence of infection and decrease the cost of treatment.
Session topic: E-poster
Keyword(s): Bortezomib, Multiple myeloma, Subcutaneous
Type: Publication Only
Background
Multiple myeloma(MM) is a clonal plasma cell malignancy. NCCN guidelines recommended bortezomib-based therapies as the first front-line treatment in patients with newly diagnosed and relapsed multiple myeloma. Oakervee H E, et al proved that PAD combination (bortezomib/doxorubicin/dexamethasone) can improve survival for previously untreated MM patients.Peripheral neuropathy(PN) is a well-known and unavoidable side effect of bortezomib, which is limited to the usage for some patients. The multi-centers clinical research suggested that subcutaneous administration of bortezomib was non-inferior to the standard intravenous route of delivery but could reduce side-effects of bortezomib, particularly in peripheral neuropathy. But China is lack of data about the usage of bortezomib.
Aims
To explore the efficacy and safety of subcutaneous injection of bortezomib in the treatment of de novo MM patients.
Methods
A total of 57 MM patients treated with bortezomib, adriamycin and dexamethasone form June 2008 to January 2015 were analyzed. Among them 28 received conventional PADiv with the intravenous bolus of bortezomib and another 29 received PADih with the subcutaneous injection of bortezomib. The efficacy and safety of two groups were evaluated.
Results
The overall response rate was 94.6% of all patients after four courses of PAD induction.67.9%, 32.1% in PADiv group and 60.7%,30.4% in PADih group achieved response>=VGPR and sCR/CR. The median follow-up of PADiv group was 40(1.5-73) months and PADih was 20(1.5-30) months. There was no difference of TTP and DFS between Two groups. But PADih group showed a more favorable OS (p=0.004)even though with a shorter period of follow-up. The statistical results showed that the most common hematologic toxicities of grade 3/4 in the PAD group were granulopenia(67.9%), leukopenia(67.9%), thrombocytopenia (67.9%) and anemia (35.7%), and non-hematologic toxicities of grade 3/4 mainly included infection (39.3%), constipation (25%), diarrhea (21.4%), peripheral neuropathy(21.4%), fever (21.4%), VZV infection (17.9%) and anorexia (17.6%). Accordingly, the hematologic toxicities of grade 3/4 in the PADih group were granulopenia(55.2%), thrombocytopenia (51.7%), leukopenia(41.4%), anemia(41.4%) and non-hematological toxicities were mainly constipation(34.5%), nausea(27.6%), anorexia(17.2%), diarrhea (17.2%) and vomiting(10.3%). A total of 27 patients(47.4%) treated with Velcade suffered from peripheral neuropathy. Incidence of PN of two groups even grade 3/4 showed no statistic difference. 39.3% PADiv patients were infected during the treatment and 3 died from severe pneumonia. The incidence of infection in PADiv and PADih group shows great difference(P=0.000). Among other grade 3/4 adverse reactions, only data of leukopenia(P=0.045) and VZV infection(P=0.023) show differences. Remarkably, six patients (21.4%) receiving PADiv due to severe PN reduced dose of Velcade or Suspended treatment. Patients treated with PADih did not appear serious infection. Average length of hospital stay per circle of PADih and PADiv group is 24, 15 days, respectively (P = 0.000). Comparison of supportive therapies including G-CSF, platelets transfusion, resuscitation, prevention of infection, nutrition and bortezomib reduction or suspension through chi-square analysis showed that proportion of platelet transfusion and prevention of infection was statistically significant (P = 0.094; P = 0.091) when alpha = 0.1. Ratio of resuscitation, anti-infection drugs, suspension or reduction of bortezomib in PADiv group is higher(P = 0.009; P = 0.002; P = 0.011).
Conclusion
The PADih regimen by changing bortezomib from intravenous bolus to subcutaneous injection significantly reduced adverse events, improved the safety of clinical application of bortezomib without affecting curative effect, and had greatly improved the overall survival due to lower incidence of infection in the PADih patients. In addition, subcutaneous bortezomib could obviously reduce the length of stay in hospital per circle and incidence of infection and decrease the cost of treatment.
Session topic: E-poster
Keyword(s): Bortezomib, Multiple myeloma, Subcutaneous
Abstract: PB2002
Type: Publication Only
Background
Multiple myeloma(MM) is a clonal plasma cell malignancy. NCCN guidelines recommended bortezomib-based therapies as the first front-line treatment in patients with newly diagnosed and relapsed multiple myeloma. Oakervee H E, et al proved that PAD combination (bortezomib/doxorubicin/dexamethasone) can improve survival for previously untreated MM patients.Peripheral neuropathy(PN) is a well-known and unavoidable side effect of bortezomib, which is limited to the usage for some patients. The multi-centers clinical research suggested that subcutaneous administration of bortezomib was non-inferior to the standard intravenous route of delivery but could reduce side-effects of bortezomib, particularly in peripheral neuropathy. But China is lack of data about the usage of bortezomib.
Aims
To explore the efficacy and safety of subcutaneous injection of bortezomib in the treatment of de novo MM patients.
Methods
A total of 57 MM patients treated with bortezomib, adriamycin and dexamethasone form June 2008 to January 2015 were analyzed. Among them 28 received conventional PADiv with the intravenous bolus of bortezomib and another 29 received PADih with the subcutaneous injection of bortezomib. The efficacy and safety of two groups were evaluated.
Results
The overall response rate was 94.6% of all patients after four courses of PAD induction.67.9%, 32.1% in PADiv group and 60.7%,30.4% in PADih group achieved response>=VGPR and sCR/CR. The median follow-up of PADiv group was 40(1.5-73) months and PADih was 20(1.5-30) months. There was no difference of TTP and DFS between Two groups. But PADih group showed a more favorable OS (p=0.004)even though with a shorter period of follow-up. The statistical results showed that the most common hematologic toxicities of grade 3/4 in the PAD group were granulopenia(67.9%), leukopenia(67.9%), thrombocytopenia (67.9%) and anemia (35.7%), and non-hematologic toxicities of grade 3/4 mainly included infection (39.3%), constipation (25%), diarrhea (21.4%), peripheral neuropathy(21.4%), fever (21.4%), VZV infection (17.9%) and anorexia (17.6%). Accordingly, the hematologic toxicities of grade 3/4 in the PADih group were granulopenia(55.2%), thrombocytopenia (51.7%), leukopenia(41.4%), anemia(41.4%) and non-hematological toxicities were mainly constipation(34.5%), nausea(27.6%), anorexia(17.2%), diarrhea (17.2%) and vomiting(10.3%). A total of 27 patients(47.4%) treated with Velcade suffered from peripheral neuropathy. Incidence of PN of two groups even grade 3/4 showed no statistic difference. 39.3% PADiv patients were infected during the treatment and 3 died from severe pneumonia. The incidence of infection in PADiv and PADih group shows great difference(P=0.000). Among other grade 3/4 adverse reactions, only data of leukopenia(P=0.045) and VZV infection(P=0.023) show differences. Remarkably, six patients (21.4%) receiving PADiv due to severe PN reduced dose of Velcade or Suspended treatment. Patients treated with PADih did not appear serious infection. Average length of hospital stay per circle of PADih and PADiv group is 24, 15 days, respectively (P = 0.000). Comparison of supportive therapies including G-CSF, platelets transfusion, resuscitation, prevention of infection, nutrition and bortezomib reduction or suspension through chi-square analysis showed that proportion of platelet transfusion and prevention of infection was statistically significant (P = 0.094; P = 0.091) when alpha = 0.1. Ratio of resuscitation, anti-infection drugs, suspension or reduction of bortezomib in PADiv group is higher(P = 0.009; P = 0.002; P = 0.011).
Conclusion
The PADih regimen by changing bortezomib from intravenous bolus to subcutaneous injection significantly reduced adverse events, improved the safety of clinical application of bortezomib without affecting curative effect, and had greatly improved the overall survival due to lower incidence of infection in the PADih patients. In addition, subcutaneous bortezomib could obviously reduce the length of stay in hospital per circle and incidence of infection and decrease the cost of treatment.
Session topic: E-poster
Keyword(s): Bortezomib, Multiple myeloma, Subcutaneous
Type: Publication Only
Background
Multiple myeloma(MM) is a clonal plasma cell malignancy. NCCN guidelines recommended bortezomib-based therapies as the first front-line treatment in patients with newly diagnosed and relapsed multiple myeloma. Oakervee H E, et al proved that PAD combination (bortezomib/doxorubicin/dexamethasone) can improve survival for previously untreated MM patients.Peripheral neuropathy(PN) is a well-known and unavoidable side effect of bortezomib, which is limited to the usage for some patients. The multi-centers clinical research suggested that subcutaneous administration of bortezomib was non-inferior to the standard intravenous route of delivery but could reduce side-effects of bortezomib, particularly in peripheral neuropathy. But China is lack of data about the usage of bortezomib.
Aims
To explore the efficacy and safety of subcutaneous injection of bortezomib in the treatment of de novo MM patients.
Methods
A total of 57 MM patients treated with bortezomib, adriamycin and dexamethasone form June 2008 to January 2015 were analyzed. Among them 28 received conventional PADiv with the intravenous bolus of bortezomib and another 29 received PADih with the subcutaneous injection of bortezomib. The efficacy and safety of two groups were evaluated.
Results
The overall response rate was 94.6% of all patients after four courses of PAD induction.67.9%, 32.1% in PADiv group and 60.7%,30.4% in PADih group achieved response>=VGPR and sCR/CR. The median follow-up of PADiv group was 40(1.5-73) months and PADih was 20(1.5-30) months. There was no difference of TTP and DFS between Two groups. But PADih group showed a more favorable OS (p=0.004)even though with a shorter period of follow-up. The statistical results showed that the most common hematologic toxicities of grade 3/4 in the PAD group were granulopenia(67.9%), leukopenia(67.9%), thrombocytopenia (67.9%) and anemia (35.7%), and non-hematologic toxicities of grade 3/4 mainly included infection (39.3%), constipation (25%), diarrhea (21.4%), peripheral neuropathy(21.4%), fever (21.4%), VZV infection (17.9%) and anorexia (17.6%). Accordingly, the hematologic toxicities of grade 3/4 in the PADih group were granulopenia(55.2%), thrombocytopenia (51.7%), leukopenia(41.4%), anemia(41.4%) and non-hematological toxicities were mainly constipation(34.5%), nausea(27.6%), anorexia(17.2%), diarrhea (17.2%) and vomiting(10.3%). A total of 27 patients(47.4%) treated with Velcade suffered from peripheral neuropathy. Incidence of PN of two groups even grade 3/4 showed no statistic difference. 39.3% PADiv patients were infected during the treatment and 3 died from severe pneumonia. The incidence of infection in PADiv and PADih group shows great difference(P=0.000). Among other grade 3/4 adverse reactions, only data of leukopenia(P=0.045) and VZV infection(P=0.023) show differences. Remarkably, six patients (21.4%) receiving PADiv due to severe PN reduced dose of Velcade or Suspended treatment. Patients treated with PADih did not appear serious infection. Average length of hospital stay per circle of PADih and PADiv group is 24, 15 days, respectively (P = 0.000). Comparison of supportive therapies including G-CSF, platelets transfusion, resuscitation, prevention of infection, nutrition and bortezomib reduction or suspension through chi-square analysis showed that proportion of platelet transfusion and prevention of infection was statistically significant (P = 0.094; P = 0.091) when alpha = 0.1. Ratio of resuscitation, anti-infection drugs, suspension or reduction of bortezomib in PADiv group is higher(P = 0.009; P = 0.002; P = 0.011).
Conclusion
The PADih regimen by changing bortezomib from intravenous bolus to subcutaneous injection significantly reduced adverse events, improved the safety of clinical application of bortezomib without affecting curative effect, and had greatly improved the overall survival due to lower incidence of infection in the PADih patients. In addition, subcutaneous bortezomib could obviously reduce the length of stay in hospital per circle and incidence of infection and decrease the cost of treatment.
Session topic: E-poster
Keyword(s): Bortezomib, Multiple myeloma, Subcutaneous
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